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MEGACE

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Megace Adverse Events Reported to the FDA Over Time

How are Megace adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Megace, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Megace is flagged as the suspect drug causing the adverse event.

Most Common Megace Adverse Events Reported to the FDA

What are the most common Megace adverse events reported to the FDA?

Death
269 (8.04%)
Deep Vein Thrombosis
152 (4.55%)
Malignant Neoplasm Progression
84 (2.51%)
Pulmonary Embolism
68 (2.03%)
Fatigue
57 (1.7%)
Asthenia
54 (1.61%)
Adrenal Insufficiency
42 (1.26%)
Oedema Peripheral
39 (1.17%)
Weight Decreased
39 (1.17%)
Dyspnoea
38 (1.14%)
Vomiting
38 (1.14%)
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Nausea
36 (1.08%)
Abdominal Pain
34 (1.02%)
Confusional State
33 (.99%)
Thrombosis
31 (.93%)
Weight Increased
28 (.84%)
Decreased Appetite
27 (.81%)
Dehydration
27 (.81%)
Headache
26 (.78%)
Diarrhoea
25 (.75%)
Drug Ineffective
25 (.75%)
Malaise
25 (.75%)
Somnolence
25 (.75%)
Anaemia
24 (.72%)
Blood Glucose Increased
24 (.72%)
Dizziness
23 (.69%)
Fall
23 (.69%)
Vaginal Haemorrhage
23 (.69%)
Haemoglobin Decreased
20 (.6%)
Cognitive Disorder
19 (.57%)
Meningioma
19 (.57%)
Pneumonia
19 (.57%)
Hypotension
17 (.51%)
Anorexia
16 (.48%)
Hepatic Failure
16 (.48%)
Hyponatraemia
15 (.45%)
Pyrexia
15 (.45%)
Blood Testosterone Decreased
14 (.42%)
Hot Flush
14 (.42%)
Tachycardia
14 (.42%)
Condition Aggravated
13 (.39%)
Disorientation
13 (.39%)
Failure To Thrive
13 (.39%)
Feeling Abnormal
13 (.39%)
Medication Error
13 (.39%)
Mental Status Changes
13 (.39%)
Rash
13 (.39%)
Abasia
12 (.36%)
Blood Sodium Decreased
12 (.36%)
Cerebrovascular Accident
12 (.36%)
Chest Pain
12 (.36%)
Erythema
12 (.36%)
Hyperhidrosis
12 (.36%)
Incorrect Dose Administered
12 (.36%)
Pain
12 (.36%)
Pain In Extremity
12 (.36%)
Tremor
12 (.36%)
Back Pain
11 (.33%)
Balance Disorder
11 (.33%)
Blood Cortisol Decreased
11 (.33%)
Blood Urea Increased
11 (.33%)
Oedema
11 (.33%)
Dry Mouth
10 (.3%)
Hallucination
10 (.3%)
Infection
10 (.3%)
Renal Failure
10 (.3%)
Thrombocytopenia
10 (.3%)
Blood Chloride Decreased
9 (.27%)
Blood Potassium Decreased
9 (.27%)
Blood Pressure Increased
9 (.27%)
Cardiac Failure Congestive
9 (.27%)
Depressed Level Of Consciousness
9 (.27%)
Electrolyte Imbalance
9 (.27%)
Feeling Cold
9 (.27%)
Heart Rate Increased
9 (.27%)
Hepatic Cirrhosis
9 (.27%)
Hypogonadism
9 (.27%)
Lung Neoplasm Malignant
9 (.27%)
Metastases To Central Nervous Syste...
9 (.27%)
Neutropenia
9 (.27%)
Renal Impairment
9 (.27%)
Abdominal Distension
8 (.24%)
Cachexia
8 (.24%)
Hypomagnesaemia
8 (.24%)
International Normalised Ratio Incr...
8 (.24%)
Myocardial Infarction
8 (.24%)
Neoplasm Malignant
8 (.24%)
Paraesthesia
8 (.24%)
Product Taste Abnormal
8 (.24%)
Prothrombin Time Prolonged
8 (.24%)
Pruritus
8 (.24%)
Venous Thrombosis
8 (.24%)
White Blood Cell Count Increased
8 (.24%)
Abnormal Behaviour
7 (.21%)
Androgen Deficiency
7 (.21%)
Arthralgia
7 (.21%)
Asthma
7 (.21%)
Cardiac Murmur
7 (.21%)
Drug Interaction
7 (.21%)
Haemorrhage
7 (.21%)
Hyperkalaemia
7 (.21%)

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This graph shows the top adverse events submitted to the FDA for Megace, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Megace is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Megace

What are the most common Megace adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Megace, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Megace is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Megace According to Those Reporting Adverse Events

Why are people taking Megace, according to those reporting adverse events to the FDA?

Decreased Appetite
504
Drug Use For Unknown Indication
392
Product Used For Unknown Indication
175
Weight Decreased
170
Anorexia
146
Increased Appetite
135
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Appetite Disorder
115
Hot Flush
58
Cachexia
50
Breast Cancer
43
Prophylaxis
38
Endometrial Cancer
25
Neoplasm Malignant
25
Hormone Replacement Therapy
19
Weight Increased
19
Hiv Wasting Syndrome
14
Breast Cancer Metastatic
11
Endometrial Sarcoma
10
Asthenia
8
Ill-defined Disorder
8
Malnutrition
7
Hormone Therapy
7
Prostate Cancer
7
Failure To Thrive
6
Uterine Cancer
6
Lung Neoplasm Malignant
6
Flushing
6
Menstrual Disorder
6
Weight Control
6
Lung Cancer Metastatic
5
Endometrial Hyperplasia
5
Sarcoma Uterus
5
Chemotherapy
5
Non-small Cell Lung Cancer
5
Hepatitis B
4
Ovarian Cancer
4
Oral Intake Reduced
4
Fibroma
3
Pancreatic Carcinoma Metastatic
3
Uterine Leiomyoma
3
Pancreatic Carcinoma
3
Cystic Fibrosis
3
Disease Progression
2
Arrhythmia
2
Progesterone
2
Endometrial Disorder
2
Pulmonary Embolism
2
Underweight
2
Menopause
2
Post Procedural Complication
2
Neoplasm
2

Drug Labels

LabelLabelerEffective
Megace EsStat Rx USA27-OCT-09
Megace EsPhysicians Total Care, Inc.30-MAR-11
MegaceE.R. Squibb & Sons, L.L.C.09-NOV-12
Megace EsPar Pharmaceutical, Inc02-APR-13

Megace Case Reports

What Megace safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Megace. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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